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510(k) K934696

ANGIOSCOPE by Intramed Laboratories, Inc. — Product Code LYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1994
Date Received
September 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Angioscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
CV
Submission Type

Other clearances by Intramed Laboratories, Inc.

  • K953258 — TITANIUM HEMOSTATIC CLIP (January 5, 1996)
  • K942457 — GRAFT THROMBECTOMY INSTRUMENTS (February 7, 1995)
  • K931792 — ARTHROSCOPE (June 13, 1994)
  • K925283 — VALVULOTOME (February 10, 1994)
  • K922114 — ENDOSCOPIC RETRIEVAL BASKET (August 3, 1992)
  • K914385 — OPTICAL VALVULOTOME (March 2, 1992)
  • K904465 — FLEXIBLE ARTHROSCOPE (December 20, 1990)
  • K903528 — LAPAROSCOPE (September 4, 1990)
  • K902444 — CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (August 30, 1990)
  • K901010 — FLEXIBLE CHOLEDOCHOSCOPE (May 22, 1990)

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  • K011793 — KSEA FIBERSCOPE (April 17, 2002)
  • K012724 — SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 (November 8, 2001)
  • K001408 — KSEA VASCULAR FIBERSCOPES (October 30, 2000)
  • K964061 — GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (February 20, 1997)
  • K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE (July 28, 1995)
  • K951721 — APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (July 11, 1995)